Editor's Note: Problems with Philips’ BiPap V30, BiPAP A30, BiPAP A40 ventilators resulted in only 7 recorded deaths and 10 injuries—far fewer than the 65 deaths and 952 injuries initially reported by the US Food and Drug Administration (FDA). In a July 10 update to the class 1 recall—the most…
Editor's Note The US Food & Drug Administration has designated recalls of Baxter’s Life2000 Ventilator and the I-Pack Injection Kit from Bausch + Lomb and subsidiary Synergetics Inc. as Class 1, the most severe category indicating serious risk of injury or death. According to FDA’s July 15 announcement, the ventilator…
Editor's Note The US Food and Drug Administration (FDA) has classified recalls by Hamilton Medical and Megadyne as Class 1 events, the most severe category indicating risk of serious injury or death. According to the agency’s July 11 report, Hamilton Medical is correcting software for its HAMILTON-C6 Medical Ventilator to…
Editor's Note A manufacturing defect in a critical component of an upper airway stimulation (UAS) system and coils prone to overheating during magnetic resonance imaging scans (MRIs) prompted The US Food & Drug administration to issue two Class 1 recalls June 8. Class 1 is the most severe category, indicating…
Editor's Note The US Food and Drug Administration has announced class 1 recalls—the most severe category indicating risk of serious injury or death—for Abbot Medical’s HeartMate System Monitor and Philips Respironics OmniLab Advanced+ (OLA+) ventilator. According to the agency’s June 28 report, the recall of the HeartMate System Monitor, part…
Editor's Note Alarm failures and missing details in instructional materials prompted the US Food and Drug Administration (FDA) to issue class 1 recalls—the most severe category indicating risk of serious injury or death—for two different ventilator models on June 27. According to the report, failure in the Ventilator Inoperative alarm…
Editor's Note The US Food & Drug Administration (FDA) has announced Class 1 recalls—the most severe category, indicating risk of serious injury or death—for three products: MEGA SOFT Pediatric Patient Return Electrodes from Megadyne, Vaporizer Sevoflurane Maquet Filling from Getinge; and Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex…
Editor's Note The US Food & Drug Administration has designated Medline Industries’ recall of the Sub-G Endotracheal Tube with Subglottic Suction, which is used to keep a patients’ airway open, as a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s June…
Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…
Editor's Note A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death. According to the agency’s May…